FDAFDA · Food and drugs·Recall number Z-1840-2020
Ivoclar Vivadent IPS e.max ZirCAD CER/inLab Start.Kit LT - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technology Product Number: 686282EN
Published May 13, 2020 · Recall initiated: April 13, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Restorations crack during the sintering process.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ivoclar Vivadent AG
- Distributor
- US Nationwide distribution.
- Lot
- Lot Numbers: Z0007Z, Z000KK, Y49356, Z006HV
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Liechtenstein
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